Atlas, and Titan MRI Sys, Cl ll EXCELART Vantage

Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report 9/5/12
Class ll:

PRODUCT

EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy. Z-2278-2012

REASON
The status display in the sequence queue window may not change from “Current” to “Done”.

RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc.,Tustin, CA on 5/13/2008. Voluntary: Firm Initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
54

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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